7:45-8:50 Breakfast
8:50-9:00 Chair’s opening remarks
Charles T. Hardy, PhD, MBA; President, Biovaluation & Analysis, Inc.
9:00 Strategic Pipeline Development: Early Stage Tactics Improve Success Rates
This session will address the challenges associated with drug delivery pipeline development. While success rates are reportedly higher and development timelines shorter in drug delivery projects compared with broad industry averages, the bad news is that it takes more projects than almost any young or small company can sustain to achieve a risk-managed portfolio.
This session will review best practices in:
Edward Tuttle, Managing Principal, Analysis Group
9:40 Ophthalmic Drug Delivery: Emerging Technologies and Strategies for Commercialization
The nexus of shifting consumer demographics and new drug delivery technologies will continue to reshape the market landscape and create new opportunities for pharmaceutical manufacturers. This presentation will review the following:
Timothy Sullivan, President and CEO, Mystic Pharmaceuticals
10:20-10:45 Break
10:45 Drug Delivery and Specialty Pharma: Should All Drug Delivery Companies Evolve into Specialty Pharma Companies?
There has been significant growth in the number of emerging, small and mid-size companies that characterize themselves as Specialty Pharmaceuticals. However, what defines a specialty pharmaceutical company and what are the challenges facing such companies? This session will provide answers to the following important questions:
Dr. Rajiv Khosla, VP Business Development Services, Biovail Pharmaceuticals
11:25 Nanotechnology, Drug Delivery and Intellectual Property Valuation
Many areas of nanotechnology have witnessed a sharp increase in the number of patents filed, including those associated with drug delivery. This results in both challenges and opportunities for potential investors and corporate collaborators.
Therefore, understanding the appropriate valuation methodologies for the intellectual property (IP) of nanotechnology is critical. Accurate IP valuation for drug delivery applications requires careful consideration of the potential end uses of a particular technology - an exercise which may draw upon expertise in several different disciplines.
Charles T. Hardy, PhD, MBA; President, Biovaluation & Analysis, Inc.
12:05-1:05 Lunch
1:05 PowderJect Needless Technology and the Delivery of Small Molecules, Proteins and Peptides
PowderJect technology aims to provide subcutaneous and systemic delivery of small molecules, proteins and peptides without the pain associated with needles/injections. The technology has already yielded a product called Zingo for rapid local delivery of lidocaine (currently under USFDA NDA review) for Anesiva, Inc. This session will cover the following:
Anil Dasu, VP Medical Device Engineering and Samantha Miller, VP Business Development; Anesiva, Inc.
1:45 Clinical Gene Therapy via Electroporation
Electroporation involves the use of brief, pulsed electric fields to temporarily permeabilize cell membranes, allowing the entry of various types of molecules such as nucleic acids and proteins into the cell.
In gene delivery, Inovio has completed a number of studies and models relating to the efficacy of electroporation in the delivery of genes at therapeutic levels and has over 40 scientific references from gene therapy publications. Inovio has several collaborations with major biotechnology and pharmaceutical companies for the delivery of genes using electroporation, which may act as a therapeutic or a preventative vaccine, and without the assistance of problematic viral delivery systems. This session will outline their experience with the technology and prospects for future development.
Dr. Michael Fons, Executive Director Corporate Development, Inovio Corp.
2:25-2:55 Networking session (break)
2:55 Drug Delivery Deal-Making from the Perspective of the Specialty Pharma Company
This session will cover the following:
Allen Downs, Sr. Exec. Director Licensing & Business Development, Purdue Pharma
3:35 High-efficiency Delivery of Peptides, Proteins, and Other Macromolecular Drugs Via Intranasal and Broader Transmucosal Routes
Advances in intranasal and other non-invasive forms of transmucosal delivery are creating new and expanded opportunities for practical clinical uses of peptides, proteins, and other macromolecular therapeutics. Recent development of a new class of transmucosal delivery enhancement agents has created opportunities for new therapeutic options across a broad spectrum of human diseases. This session will examine the challenges and opportunities in the field of intranasal/transmucosal drug delivery.
Dr. Edward T. Maggio, CEO and Director, Aegis Therapeutics
4:15 Close of Day Two